NIH loosens stem cell consent rules

Final rules for human embryonic stem (ES) cell research, announced this afternoon (July 6) by the National Institutes of Health, require strict documentation detailing voluntary donation of embryos leftover from in-vitro fertilization procedures, but they also contain a mechanism for approving individual cell lines that don't meet the letter of the law but still adhere to the spirit of informed consent.
Human embryonic stem cellsImage: Wikimedia/PLoSThe draft guidelines proposed in April expli

By Elie Dolgin | July 6, 2009

Final rules for human embryonic stem (ES) cell research, announced this afternoon (July 6) by the National Institutes of Health, require strict documentation detailing voluntary donation of embryos leftover from in-vitro fertilization procedures, but they also contain a mechanism for approving individual cell lines that don't meet the letter of the law but still adhere to the spirit of informed consent.

Human embryonic stem cellsImage: Wikimedia/PLoS

The draft guidelines proposed in April explicitly required certain types of informed consent forms showing that cells were first freely donated for scientific research generally and then for stem cell research specifically. Those rules will apply to all new cell lines created after the rules go into effect tomorrow, the linkurl:final guidelines;http://stemcells.nih.gov/policy/2009guidelines.htm say, but there's a loophole for grandfathering in older cell lines.
After poring over nearly 50,000 comments on its proposals, the NIH decided to form a working group to also consider pre-existing ES cell lines that don't perfectly match the new protocols but meet certain "core principles of voluntary informed consent," linkurl:Raynard Kington,;http://www.nih.gov/about/director/index.htm the NIH's acting director, said in a teleconference.
The working group of "around 10 or so" -- which should be up and running within one to two months -- will review any and all pre-July 7, 2009, US-made lines submitted to it on a case by case basis, as well as any cells created abroad that meet ethical criteria "at least equivalent" to US standards, Kington said. The group will then make recommendations to the NIH director's advisory committee, which will offer final advice regarding which cells to fund. All eligible ES cell lines will then be catalogued on a central, online master list.
"We agreed that it made sense to have an alternative pathway so that we weren't retroactively applying a standard that exists now," said Kington, citing an "evolution of the standard of the procedure for informed consent."
Kington said it was "premature" to judge which existing cell lines will be approved, including which of the 21 so-called Bush cell lines that were eligible under the previous regulations will still be fundable. The rules still ban funding for stem cells from embryos created solely for research purposes.
"Overall, the administration gets high marks for taking a thoughtful and balanced approach," said Massachusetts General Hospital's linkurl:David Scadden,;http://www.hms.harvard.edu/dms/immunology/fac/Scadden.html co-director of the Harvard Stem Cell Institute, in an email. He noted that the members of the working group have yet to be named, but is confident that the NIH will appoint those with "substantive credentials."
linkurl:Stephen Duncan,;http://www.mcw.edu/cellbiology/stephenduncandphil.htm a stem cell researcher at the Medical College of Wisconsin in Milwaukee, called the guidelines a "reasonable compromise" between banning all cell lines that don't meet current best standards and blindly funding all previously approved lines.
"I'm really relieved to get here," linkurl:M. William Lensch,;http://daley.med.harvard.edu/assets/Willy/willy.htm a senior scientist at Children's Hospital Boston and the Harvard Medical School, told __The Scientist__. "It's taken a long time to get to today where we have a set of guidelines where if you meet these points you can get NIH funding for human embryonic stem cell research." Lensch noted, however, that the working board deliberations will be time-consuming and somewhat "superfluous" because the Institutional Review Boards that manage informed consent processes already undergo rigorous NIH oversight. Referring to the many lines created at Children's Hospital Boston, Lensch said, "We have confidence that we've done this well and they're going to pass muster, but how long is it going to take?"
Harvard's linkurl:George Daley;http://daley.med.harvard.edu/ praised the new guidelines as a "major step forward" for human ES cell research. "I predict that a treasure trove of lines will be made available to the stem cell research community, and that this will translate into vital new medical knowledge," he said in a statement. But he was disappointed that the NIH did not make funds eligible for cell lines made explicitly for research via directed IVF, nuclear cloning, or parthenogenesis. "It is my hope that the discussion about the scientific merits of all forms of stem cells will continue at NIH, so that decisions can be made purely according to scientific merit and not political considerations," he said.
Kington said that there has not yet been a sufficient public consultation on funding ES cell research from embryos other than those left-over from fertility treatments. "We believe that the policy that we put forward now is the right policy for where we are scientifically now," he said.
**__Related stories:__***linkurl:Benefits of the stem cell ban;http://www.the-scientist.com/news/display/55752/ [8th June 2009]*linkurl:Will new ESC rules hurt research?;http://www.the-scientist.com/blog/display/55692/ [14th May 2009]*linkurl:NIH, stem cells: IVF ok, not SCNT;http://www.the-scientist.com//blog/display/55623/ [17th April 2009]